Analysis of biomarkers is fast becoming the preferred method for early detection of disease, patient stratification and monitoring efficacy of treatment. Rapid and highly sensitive detection of changes in a biomarker is often technically impossible, or may require a cumbersome procedure involving multiple processing steps, necessitating large sample volumes and a prolonged diagnosis/prognosis timeline. The sample from a patient is often of a limited volume and not amenable to processing or to procedures requiring multiple steps that extend the processing time.
Current methods for detecting molecular biomarkers or biological analytes of interest for diagnostic applications rely primarily on extraction of body fluid (e.g., blood, interstitial tissue fluid) from a patient. It is from this sample of fluid that specific biomarkers are assayed. More recent inventions do not directly sample clinically relevant biomarkers from the site of application, but rather, require further processing of body fluids. Other diagnostic methodologies that are not based on molecular assaying, e.g., biopsies, are usually cumbersome and fraught with misdiagnosis risks due to their inherently visual and subjective nature. For localized, non-circulating biomarkers, however, this has often been the only diagnostic option to-date.
There is a need in the art for better means for detecting and analyzing biomarkers present in the body of subjects having or at risk of developing various diseases or disorders. The present invention addresses this and other needs.